The OncLive® News page includes the latest in clinical oncology news, including breaking regulatory decisions, clinical trial findings, pivotal and practice-changing data published in academic peer-reviewed journals, and more across solid and hematologic malignancies. Regulatory news includes new drug approvals by the FDA and European Union, priority review and breakthrough therapy designations, and orphan drug and fast track statuses.
ADCs, Novel Targets Represent Next Wave of Treatment Advances in mCRPC
March 11th 2023Patients with metastatic castration-resistant prostate cancer have traditionally been burdened by a poor outlook; however, emerging therapeutic targets and novel agents directed at them are poised to affect change in this population.
Response-Guided Therapy Is the Next Frontier for Tailoring Therapy in HER2+ Breast Cancer
March 10th 2023Lisa M. Carey, MD, ScM, FASCO, discusses upcoming treatments that could impact standard-of-care practices and the continually evolving role of antibody-drug conjugates role in the breast cancer treatment paradigm.
China’s NMPA Accepts BLA for Enfortumab Vedotin in Locally Advanced/Metastatic Urothelial Cancer
March 10th 2023The Center for Drug Evaluation of the China National Medical Products Administration has accepted the biologics license application for enfortumab vedotin for the treatment of patients with locally advanced or metastatic urothelial cancer who received prior treatment with a PD-1/L1 inhibitor and platinum-based chemotherapy.
Pembrolizumab Plus Chemotherapy Meets OS End Point in Advanced Malignant Pleural Mesothelioma
March 10th 2023First-line treatment with the combination of pembrolizumab and chemotherapy generated a statistically significant and clinically meaningful improvement in overall survival compared with chemotherapy alone in patients with unresectable advanced or metastatic malignant pleural mesothelioma.
Durvalumab-Based Treatment Before and After Surgery Improves EFS in Early-Stage NSCLC
March 9th 2023Durvalumab plus neoadjuvant chemotherapy followed by surgery and adjuvant single-agent durvalumab significantly improved event-free survival vs neoadjuvant chemotherapy and surgery alone in patients with resectable stage IIA-IIIB non–small cell lung cancer.
Study Shows Women Over Age 65 With Low-risk Breast Cancer Could Skip Postoperative Radiation Therapy
March 9th 2023A recently published study in the New England Journal of Medicine provides further data to support that certain female patients over age 65 can achieve positive outcomes without postoperative radiation.
Adjuvant Osimertinib Elicits OS Improvement in Early-Stage EGFR-Mutated NSCLC
March 9th 2023Osimertinib produced a statistically significant and clinically meaningful improvement in overall survival compared with placebo as adjuvant treatment for patients with stage IB, II, or IIIA, EGFR-mutated non–small cell lung cancer after complete tumor resection with curative intent.
FDA Grants Fast Track Designation to IK-175 in Combination With Nivolumab in Urothelial Carcinoma
March 8th 2023The FDA has granted a fast track designation to the novel aryl hydrocarbon receptor antagonist IK-175 in combination with nivolumab for the treatment of patients with advanced urothelial carcinoma who have progressed on or within 3 months of receiving the last dose of checkpoint inhibitors.
Ruxolitinib Demonstrates 6-Month Hematocrit Reduction in Polycythemia Vera
March 8th 2023Treatment with ruxolitinib significantly reduced hematocrit levels and the number of yearly phlebotomies in patients with polycythemia vera, according to findings from a prespecified futility analysis of the phase 2b RuxoBEAT trial.
FDA Accepts BLA Resubmission for Remestemcel-L in Pediatric Steroid-Refractory aGVHD
March 8th 2023The FDA’s Office of Therapeutic Products has accepted a resubmission of the biologics license application (BLA) for remestemcel-L for the treatment of pediatric patients with steroid-refractory, acute graft-vs-host-disease.
Updated MAGNITUDE Data Support Niraparib Combination in mCRPC and HRR Gene Alterations
March 8th 2023Eleni Efstathiou, MD, PhD, expands on the updated interim data from the MAGNITUDE trial and sheds light on the utility of PARP inhibitor combinatorial strategies in patients with mCRPC and HRR gene alterations.
ADCs Advance HR+/HER2– Breast Cancer Treatment Paradigm
March 7th 2023As more antibody-drug conjugates emerge and investigators foresee fam-trastuzumab deruxtecan-nxki moving forward in lines of treatment for metastatic disease, the treatment landscape of hormone receptor–positive, HER2-negative breast cancer continues to expand and shift.
New Generation of TKIs Challenge Standards of Care in Newly Diagnosed Ph+ ALL
March 7th 2023The advent of effective first-generation TKIs has allowed for improvements among patients with Philadelphia chromosome–positive disease, which is traditionally associated with a poor prognosis, as it generally does not respond to conventional chemotherapy options.